CD200AR-L and Allogeneic Tumor Lysate Vaccine Immunotherapy for Recurrent HGG and Newly Diagnosed DMG/DIPG in Children and Young Adults
Eligible age
2–25 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
This is a single center Phase I study of a new adjuvant CD200 activation receptor ligand, CD200AR-L, in combination with imiquimod and GBM6-AD vaccine to treat malignant glioma in children and young adults. The primary objective of this study is to determine the maximum tolerated dose (MTD) of CD200AR-L when given with a fixed dose of GBM6-AD vaccine, imiquimod, and a single dose of radiation for patients with recurrent High Grade Glioma (HGG) or following standard of care therapy radiation therapy for newly diagnosed Newly Diagnosed Diffuse Midline Glioma/Diffuse Intrinsic Pontine Glioma (DIPG/DMG).
Sponsor: OX2 Therapeutics
You may qualify if…
- ✓ Histologically confirmed newly diagnosed DIPG/DMG with documented H3K27M alteration (based on IHC or DNA sequencing performed in a CLIA-certified laboratory) or recurrent HGG. Patients cannot enroll until they are a minimum of 14 days and preferably within 30 days from the last dose of radiation.
- ✓ Diagnosis of recurrent HGG based on MRI findings. Recurrent HGG must have received standard of care radiation at diagnosis. Prior biopsy material will be required to confirm diagnosis of HGG; however, biopsy of the recurrent/progressive lesion will not be required for study enrollment.
- ✓ Maximal safe resection is preferred prior to clinical trial enrollment if indicated and feasible.
- ✓ Clinically stable on a dose of corticosteroids not to exceed an equivalent of dexamethasone 0.1 mg/kg/day (maximum 4 mg) for at least 2 weeks prior to study enrollment.
- ✓ Prior therapy wash-out is required
- ✓ Minimum of 28 days since last dose of any targeted therapy (including bevacizumab), immunotherapy, investigational agents.
- ✓ Minimum of 10 days since any anti-cancer intervention: cytoreductive surgery/laser ablation and a minimum of 28 days since any viral therapy
- ✓ Voluntary written consent obtained by patient if ≥18 years of age or a parent or guardian if \<18 years of age before the performance of any study-related procedure not part of standard medical care
You may not qualify if…
- ✕ Known sensitivity to the GBM6-AD tumor lysate vaccine, CD200AR-L, or imiquimod.
- ✕ Unable to complete a standard upfront course of radiotherapy due to disease progression or intolerance of therapy.
- ✕ Radiographic evidence of diffuse leptomeningeal disease.
- ✕ Prior history of malignancy within 5 years of enrollment.
- ✕ Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
- ✕ Concurrent use of tumor treatment field devices (e.g., Optune) - permitted until the time of consent.
- ✕ History of any laboratory findings consistent with any uncontrolled immune system abnormalities such as hyper-immunity (e.g., autoimmune diseases, thyroid dysfunction, lupus, scleroderma, etc.) and hypo-immunity \[e.g., myelodysplastic disorders, marrow failures, human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), transplant immune-suppression, etc.\]. Any known autoimmune disease must be clinically silent and without associated laboratory abnormalities for at least 1 year in the absence of any disease directed therapy or systemic steroids.
- ✕ Any conditions that could potentially alter immune function (e.g., HIV/AIDS, hepatitis B, untreated hepatitis C, multiple sclerosis, renal failure).
Where it's recruiting
Minneapolis
Source: ClinicalTrials.gov · NCT06305910 · last updated 2024-03-12